Amgen announced that the FDA has approved Xgeva (denosumab), a RANK (Receptor Activator for Nuclear Factor κ B) ligand inhibitor, for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors. This approval was based on data from three Phase 3 head-to-head trials that evaluated Xgeva versus Zometa (zoledronic acid, from Novartis) in 5,700 patients with >50 tumor types. Xgeva demonstrated a clinically meaningful improvement in preventing SREs compared to Zometa. In patients with breast or prostate cancer and bone metastases, Xgeva was superior to Zometa in reducing the risk of SREs. In patients with bone metastasis due to other solid tumors or bone lesions due to multiple myeloma, Xgeva was noninferior (trending towards superiority) to Zometa in reducing the risk of SREs.

Xgeva is expected to be available by the end of November 2010.

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